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Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 14, 2007
Last updated: June 14, 2012
Last verified: June 2012
This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine. An additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be followed for a total of 2 years.

Condition Intervention Phase
Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of solicited local and general AEs. [ Time Frame: During a 7 days follow-up after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs. [ Time Frame: During a 31 days follow-up period after each vaccination ]
  • Occurrence and relationship to vaccination of any SAEs. [ Time Frame: Throughout the study period ]
  • Haematological and biochemical parameters. [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ]

Secondary Outcome Measures:
  • Anti-gB antibody avidity in all groups; [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ]
  • Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
  • Anti-CMV tegument proteins antibody response in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
  • Frequencies of CD4/CD8 T-cells with antigen-specific IFN-g, IL-2, TNF-a and/or CD40L secretion/expression to gB as determined by ICS in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]
  • Anti-Herpes simplex virus (HSV) gD antibody response in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]
  • Anti-glycoprotein B (gB) antibody concentrations in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
  • Anti-CMV Western Blot in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Intramuscular injection, 3 doses

Detailed Description:
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol. The section impacted by the change is Key inclusion & exclusion criteria. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Male between, and including, 18 and 40 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • The subject consents to being informed of his CMV and HSV serostatus.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Seronegative for CMV.
  • Previously completed routine childhood vaccinations to the best of his knowledge.

Exclusion Criteria:

  • The HSV serologic status.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any chronic drug therapy to be continued during the study period.
  • Receipt of live attenuated vaccines within 30 days of study vaccine administration.
  • Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections within 14 days of study vaccine administration.
  • Prior receipt of the adjuvant or any of its components being used in this study.
  • Previous vaccination against CMV.
  • History of recurrent herpes simplex infection (more than 1 episode per year).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Hepatitis B infection or hepatitis C infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness including but not limited to diabetes mellitus and thyroid disease
  • History of any neurologic disorders or seizures except people with febrile convulsions before the age of 5.
  • History of malignancy
  • Acute disease at the time of enrollment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Decreased renal function
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of chronic alcohol consumption and/or drug abuse.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00435396

GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00435396     History of Changes
Other Study ID Numbers: 108890
109211 ( Other Identifier: GSK )
Study First Received: February 14, 2007
Last Updated: June 14, 2012

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017